Innovations in Dementia Empowerment and Action

NCT03550131 | Completed Results DMC

• 2 other identifiers: STUDY000030761R01AG055488-01A1
• Study Type: interventional
• Target: 322
• Locations: 1 country
• Sites: 1

Brief Summary

The lack of efficacious research-based interventions for such vulnerable older adults with Alzheimer's disease and related dementias (AD/RD) and their caregivers (CGs) is a significant public health problem. Caregiving of sexual/gender minority older adults with AD/RD is of concern due to social stigma, marginalization, and isolation, which may be barriers to sustaining caregiving. It is necessary and timely to translate evidence-based culturally adaptable interventions for this underserved and stigmatized population. Reducing Disability in Alzheimer's Disease (RDAD) has been evaluated in a randomized controlled trial and has shown to successfully train community-dwelling CR (care receiver)-CG dyads to increase the physical activity and functioning of individuals with AD/RD and their CGs and to teach CGs techniques for managing behavioral symptoms of CRs. RDAD consequently decreases stress of CGs, delays institutionalization of CRs, and increases health related quality of life (HRQOL) of CRs and CGs. Thus, this study will evaluate the effect of the standard RDAD among lesbian, gay, bisexual, and transgender (LGBT) CRs with AD/RD and their CGs, and this study will test a personalized intervention tailored to better respond to distinct risks experienced by CGs and LGBT CRs with AD/RD, addressing unique sexual/gender minority CG risk factors (e.g., identity management, stigma-related adverse or traumatic life events, and lack of social support).

Conditions

Alzheimer Disease; Dementia; Mild Cognitive Impairment; Parkinson Disease Dementia; Lewy Body Dementia; Vascular Dementia

Keywords

LGBT

Outcome Measures

Primary Outcomes (1)

• Change in Physical Activity of Care Recipient

  Measured by the days of aerobic activity for at least 30 minutes in the past week with higher numbers indicating more days of activity.

  Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months

Secondary Outcomes (5)

• Depression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10)

  Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months

• Quality of Life in Alzheimer's Disease, Care Recipient

  Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months

• Memory-Related Disturbance, Care Recipient

  Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months

• Physical Functioning of Care Recipient: Medical Outcomes Study 36-Item Short Form (SF-36)

  Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months

• Perceived Stress of Care Partner

  Baseline, 6 weeks (Pre-treatment), 13 weeks (Post-treatment), 30 weeks, 13 months

Study Arms (2)

Standard intervention

ACTIVE COMPARATOR

Reducing Disabilities in Alzheimer's Disease (RDAD): 9 60-minute virtual sessions for 6 weeks and 4 15-minute follow-up phone sessions for 4 months

Behavioral: Reducing Disabilities in Alzheimer's Disease (RDAD)

Personalized intervention

EXPERIMENTAL

Innovations in Dementia Empowerment and Action (IDEA): 9 60-minute virtual sessions for 6 weeks and 4 15-minute follow-up phone sessions for 4 months

Behavioral: Innovations in Dementia Empowerment and Action (IDEA)

Interventions

Innovations in Dementia Empowerment and Action (IDEA) BEHAVIORAL

The IDEA intervention has the same exposure to treatment as the RDAD intervention. The behavioral component of the treatment manual is adapted to incorporate 3 risk factors that are empirically known to affect midlife and older LGBT populations.These include: 1) identity management; 2) stigma-related adverse/traumatic life events; and 3) lack of social support. All other aspects of the treatment are preserved.

Also known as: Personalized RDAD

Personalized intervention

Reducing Disabilities in Alzheimer's Disease (RDAD) BEHAVIORAL

The RDAD intervention includes behavioral management training for caregiver and activities and exercise training for caregiver and care receiver.

Also known as: Standard RDAD

Standard intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age at enrollment is 50 years of age or older
• Have dementia, (e.g., Alzheimer's disease, mild cognitive impairment, Vascular dementia, Parkinson's disease, Lewy Body dementia) or memory loss significant enough to affect daily activities
• Living in the community, not in a care facility.
• Living in the U.S.
• Either the care receiver or care giver must self-identify as LGBT (or sexual or gender non-binary or same sex sexual behavior)
• Provide care to the care recipient with dementia.
• Willing to spend 30 minutes daily for study activities (or coordinate for someone to.)
• Unpaid
• Live in the community, not in a care facility
• Living in the U.S.
• Neither care receiver nor caregiver:
• Has known terminal illness (with death anticipated within the next 12 months)
• Was hospitalized for a psychiatric disorder in the 12 months prior to baseline
• Is currently suicidal or having major hallucinations or delusions
• Plans to move to long term care setting within 6 months of enrollment.

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

Location

Related Publications (1)

• Fredriksen-Goldsen KI, Teri L, Kim HJ, Jones-Cobb B, LaFazia D, McKenzie G, Petros R, Jung H, Oswald AG, Hoy-Ellis C, Emlet C. Innovations in Dementia Empowerment and Action: RCT for Underserved Communities. J Am Geriatr Soc. 2026 Jan;74(1):119-131. doi: 10.1111/jgs.70189. Epub 2025 Dec 12.

  PMID: 41387197 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Cognitive Dysfunction; Lewy Body Disease; Dementia, Vascular

Interventions

Amyloid beta-Protein Precursor

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Amyloidogenic Proteins; Amyloid; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Protein Precursors; Protease Nexins; Proteinase Inhibitory Proteins, Secretory

Results Point of Contact

• Title: Dr. Karen Fredriksen-Goldsen
• Organization: University of Washington

fredrikk@uw.edu

206-543-5722

Study Officials

• Karen Fredriksen-Goldsen, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants receiving intervention will not be informed whether it is the standard or personalized treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study will utilize a 2-group randomized controlled trial design including 2 pre-intervention and 4 post-intervention assessments. The comparator group (standard intervention) will have 112 caregiver-care receiver dyads, and the experimental group (personalized intervention) will have 113 caregiver-care receiver dyads.

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: June 8, 2018
• Study Start: December 5, 2018
• Primary Completion: May 16, 2023
• Study Completion: May 16, 2023
• Last Updated: July 25, 2024
• Results First Posted: July 25, 2024

Record last verified: 2024-07

Locations

US (1)